DAT TEST FOR CHAGAS' DISEASE— 510(k) K834328

Name: FDA 510(k) clearance K834328
Creator: U.S. Food and Drug Administration
Published: 1984-03-02

Substantially Equivalent

Sero-Immuno Diagnostics, Inc.

FDA 510(k) clearance K834328 for DAT TEST FOR CHAGAS' DISEASE, Substantially Equivalent on 1984-03-02. Applicant: Sero-Immuno Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Sero-Immuno Diagnostics, Inc.
Product code: Code GNE
Device class: Class 1
Regulation: 21 CFR 866.3870
Advisory panel: Microbiology
Date received: 1983-12-09
Decision date: 1984-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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